• Skip to primary navigation
  • Skip to main content
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • COVID-19 Annoucements
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Strategic Plan, 2020-2023
    • Committees
      • Descriptions and Video Updates
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
  • Meetings
    • COVID-19 Announcements
    • SAGES 2020 Meeting Information
    • 2021 Scientific Session Call For Abstracts
    • 2021 Emerging Technology Session Call For Abstracts
    • 2018 Prevent BDI Consensus Conference
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • Leadership Development and Health Policy Conference Videos
      • SAGES Quality Summit Meeting
      • SAGES 2019
      • SAGES 2018
      • SAGES 2017
      • SAGES 2016
      • SAGES 2015
      • SAGES 2014
      • SAGES 2013
    • Related Meetings Calendar
  • Membership
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • COVID-19 Annoucements
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • Troubleshooting Guides
  • Education
    • SAGES.TV Video Library
    • Virtual Hernia Clinic
    • The SAGES Safe Cholecystectomy Program
    • The Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • The SAGES HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Endorsed Courses
    • SAGES Robotics Fellows Courses
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Educational Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES Quality Initiative
    • SAGES OR SAFETY Video
    • SAGES at Cine-Med
      • SAGES Top 21 MIS Procedures
      • SAGES Pearls
      • SAGES Flexible Endoscopy 101
      • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • SAGES Research Opportunities
    • SAGES Endorsed Courses
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
    • Fellowship Certification
  • Search
    • COVID-19 Announcements
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Blog
    • All Blog Posts
    • COVID-19
    • Notes from the Battlefield
    • A (Positive) Way Forward
    • President Posts
  • Log In

VISTASEAL

September 21, 2020 by Timothy Shea Snow

Ethicon, Inc. received FDA approval for the VISTASEAL Dual Applicator on April 10, 2019.

VISTASEAL is a single-use coagulant device that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate intraoperative bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue.

There are a variety of applicators that exist for utilization in both the open and laparoscopic setting. The human fibrin sealant comes in prefilled packaging that allows for easy set-up, and does not require mixing. The dual applicator mixes the fibrinogen and thrombin as the plunger is depressed. It is shipped and stored frozen, and has a shelf life of up to 2 years. VISTASEAL typically requires 5 minutes of thawing time in a sterile water bath (37°C) and is then ready for immediate use. The product boasts a broader range of working temperature (2°C-37°C) that allows for improved flexibility in the OR. It also utilizes an airless system that allows for both drip and spray applications. The product does not require the use of pressurized carbon dioxide external spray equipment for application.

Biocompatibility of the materials for the VISTASEAL Dual Applicator device was assessed and there were no biocompatibility risks associated with the materials selected. Hemocompatibility tests were also performed as some of the device components have direct contact with the Fibrin Sealant. These tests demonstrated that device materials are similar to the predicate device and are clinically acceptable for the delivery of the Fibrin Sealant.

The FDA determined this device is substantially equivalent to the EVICEL Airless Spray Accessory and EVICEL 6 cm Tip through its spray and drip application of Fibrin Sealant.

VISTASEAL is approved for treating mild to moderate intraoperative bleeding that cannot be controlled by standard surgical techniques. It is effective for use in heparinized patients

VISTASEAL should not be directly injected into the circulatory system due to a risk of thromboembolic events. It is not recommended for brisk or severe arterial bleeding. Its use should be avoided in patients with a history of severe systemic allergic reactions or anaphylaxis to human blood products.

Post Views: 179

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

Contact SAGES

Society of American Gastrointestinal and Endoscopic Surgeons
11300 W. Olympic Blvd Suite 600
Los Angeles, CA 90064 USA
webmaster@sages.org
Tel: (310) 437-0544

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Newsletter Subscription

  • This field is for validation purposes and should be left unchanged.

Important Links

SAGES 2020 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

[footer_backtotop] · Log in

Copyright © 2021 Society of American Gastrointestinal and Endoscopic Surgeons · Legal
· Managed by BSC Management, Inc